What can we expect during the VPP uniform inspection?
After you have submitted your application and payment, your pharmacy may be inspected at any time. You are expected to be familiar with, and be operating under, all applicable regulations. The inspection is a snapshot in time.
As this is a general inspection, some items may not be required by the state of residence. The VPP inspection observes for compliance with USP Chapters <795> and <797>, as applicable. We do not make a determination of “passed” or “compliant” with regard to any specific state regulations. It is up to each individual state to determine compliance based on the findings of the VPP inspection.
The General Pharmacy Inspection covers informational questions in the following areas:
- General Operations and Licensure
- Personnel
- Facility and Security
- Product Receipt and Inventory
- Prescription Processing
- Patient Counseling and Communication
- Quality Assurance/Quality Improvement Program
The information and comments obtained in the nonsterile compounding and sterile compounding supplement inspections are based on USP Chapters <795> and <797>, respectively. An inspection against current Good Manufacturing Practices (cGMPs) is not conducted.
The Nonsterile Compounding Inspection covers informational questions in the following areas:
- General Operations
- Component Selection and Use
- Beyond-Use Dating (BUD)
- Environment
- Training
- Compounding Equipment
- Documentation
- Compounding Procedures
- Finished Preparation Release Checks and Tests
- Patient Counseling and Communication
The Sterile Compounding Inspection covers informational questions in the following areas:
- General Operations
- Component Selection and Use
- Environment
- Cleaning and Disinfection
- Training
- Garbing
- Environmental Monitoring
- Compounding Equipment
- Compounding Procedures (including BUD, documentation, sterilization)
- Finished Preparation Release Checks and Tests
- Patient Counseling and Communication